Healthcare Industry News: stent thrombosis
News Release - May 19, 2009
NEVO Sirolimus-Eluting Coronary Stent Yields Superior Results to Taxus Liberte Stent in Pivotal Clinical TrialNew Approach to Coronary Stenting Shows Superior Results in Key Six-Month Safety and Efficacy Endpoints
BARCELONA, Spain--(HSMN NewsFeed)--At six months, the NEVO(TM) Sirolimus-eluting Coronary Stent, incorporating RES Technology(TM), was superior to the Taxus(R) Liberte(R) Stent in reducing tissue growth within the stent that can potentially lead to repeat procedures, in new clinical study results released today. In addition, no reports of stent thrombosis were reported in patients treated with NEVO(TM) through six months.
The results of the NEVO RES I study comparing these two drug-eluting stents were presented during Late Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
“We are extremely pleased with the results from this trial and believe NEVO(TM) has the potential to return Cordis to global leadership in the drug-eluting stent market,” said Seth Fischer, Company Group Chairman and Worldwide Franchise Chairman, Cordis Corporation.
NEVO(TM) is the first drug-eluting stent utilizing RES Technology(TM), which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents have 100 percent of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.
The NEVO(TM) Sirolimus-eluting Coronary Stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomized clinical trial. Specifically, late lumen loss was reduced by 64 percent in the NEVO(TM) arm as compared to the Taxus(R) Liberte(R) arm (0.13 mm compared to 0.36 mm, p<0.001). In-stent late lumen loss, which is tissue growth within a stent, reduces the diameter of the lumen thus restricting blood flow through the stent and can potentially lead to major adverse coronary events, also known as MACE.
In addition, NEVO(TM) also showed superior angiographic results to the Taxus(R) Liberte(R) Stent in reducing restenosis, a reblockage in a stent, at six months. Angiographic restenosis was reduced 86 percent (1.1 percent in the NEVO(TM) arm compared to 8.0 percent in the Taxus(R) Liberte(R) arm, p<0.002).
NEVO(TM) also reduced the incidence of MACE (major adverse coronary events) by more than 40 percent compared to the Taxus(R) Liberte(R) Stent (4.1 percent vs. 7.0 percent respectively; p=0.226). MACE events occurring between hospital discharge and six months were reduced 67 percent from 4.8 percent with the Taxus(R) Liberte(R) Stent to 1.6 percent with NEVO(TM) (p=0.08).
NEVO RES I was not designed to show differences in clinical outcomes, however, patients treated with NEVO(TM) had numerically lower rates of events with respect to target lesion revascularization (1.6 percent for NEVO(TM) vs. 3.2 percent for the Taxus(R) Liberte(R) Stent; p=0.33) and the composite of death or heart attack (2.6 percent vs. 4. 3 percent respectively; p=0.26) compared to patients receiving the Taxus(R) Liberte(R) Stent.
stent thrombosis can be a significant clinical issue with coronary stents and frequently results in heart attacks or death. Based on the ARC (Academic Research Consortium) definitions of stent thrombosis, which have been adopted by the interventional cardiology community, there were no reports of stent thrombosis in the 202 patients receiving NEVO(TM) while there were two reports of stent thrombosis in the 192 patients receiving the Taxus(R) Liberte(R) Stent, both of whom were on dual anti-platelet therapy at the time.
“In this trial, NEVO(TM) was superior to Taxus(R) Liberte(R) in a number of key safety and efficacy measures, including the primary end-point of late lumen loss,” said Christian Spaulding, M.D., F.A.C.C., Professor of Cardiology, Assistance Publique-Paris Decartes University Hospitals, Paris, France and one of three primary investigators of the NEVO RES I trial. “We also saw an emerging safety profile with NEVO(TM) that adds to our enthusiasm about the potential of this drug-eluting stent for patients with coronary artery disease.”
Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation noted, “Not only did NEVO(TM) significantly outperform Taxus(R) Liberte(R) in important measures but these results also indicate that the potential for a strong safety profile supporting the opportunity for patient-specific tailoring of the drugs traditionally needed to prevent thrombosis is quite promising.”
Dr. Rogers continued, “Based on these results, the potential for a strong safety profile with NEVO(TM) is quite promising. NEVO(TM) is designed to improve patient outcomes by providing a unique vascular safety profile, the proven efficacy of Sirolimus and excellent deliverability.”
Results in Diabetic Patients in NEVO RES I
It is widely known that patients with diabetes tend to present with more complex coronary lesions and are more challenging to treat. In the NEVO RES 1 study, a similar magnitude of benefit of the NEVO(TM) Sirolimus-eluting Coronary Stent over the Taxus(R) Liberte(R) Stent was seen in patients with diabetes as in patients without diabetes.
In a pre-specified subset analysis of the 65 patients with diabetes completing six-month follow up to date, there was a 60 percent reduction in in-stent late lumen loss with NEVO(TM) versus the Taxus(R) Liberte(R) Stent (0.17 mm compared to 0.42 mm, p<0.03). The magnitude of the differences seen in favor of NEVO(TM) was similar to the 65 percent reduction seen in 277 non-diabetic patients (0.12 mm, compared to 0.34 mm in the Taxus(R) Liberte(R) arm, p<0.001).
NEVO RES I Study Overview
The NEVO RES I study is a randomized, multi-center comparison of the NEVO(TM) Sirolimus-eluting Coronary Stent to the Taxus(R) Liberte(R) Stent in de novo native coronary artery lesions. Key secondary endpoints include target lesion failure, target vessel failure, major adverse cardiac events (MACE), stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at six months. A subset of patients in each treatment arm was evaluated via intravascular ultrasound (IVUS) at six months.
The study involved 394 patients at 40 sites throughout Europe, South America, Australia and New Zealand. Patients received clinical follow-up at 30 days and six months and will be followed annually through five years.
Data from this trial will support a regulatory filing for a CE mark in countries outside the United States.
The NEVO(TM) Sirolimus-eluting Coronary Stent is an investigational device. It is not yet approved or available for sale in any market.
About the NEVO(TM) Sirolimus-eluting Coronary Stent
NEVO(TM) is made of cobalt chromium, which makes the stent flexible and conformable with thin struts to maximize vessel coverage. The biodegradable polymer used to contain and release Sirolimus facilitates rapid endothelialization and results of pre-clinical studies indicated no greater inflammation than seen with bare metal stents.
NEVO(TM) also contains the same drug, Sirolimus, as the CYPHER(R) Sirolimus-eluting Coronary Stent, which has now been used in more than three million people worldwide. Data supporting the safety and efficacy of Sirolimus in coronary applications is now available out to six years, and this body of clinical evidence is completely unmatched by any other anti-restenotic stent.
Upcoming Clinical Trials for NEVO(TM)Sirolimus-eluting Coronary Stent
Cordis Corporation also announced today additional information of the study designs for upcoming clinical trials for NEVO(TM).
NEVO II will be a global, randomized, non-inferiority trial comparing NEVO(TM) to the Xience V(TM) Everolimus-eluting Coronary Stent. The study plans to enroll several thousand patients with coronary artery disease and will include expanded enrollment in multiple patient subgroup. The primary endpoint of the study is target lesion failure at 12-months. The study will be led by Patrick Serruys, M.D., Erasmus University, Rotterdam, The Netherlands; Stephen Windecker, M.D., University of Bern, Switzerland; and Manual Sabate, M.D., Hospital de Sant Pau, Barcelona, Spain. Results from this trial will provide long-term data in support of a Pre-market approval (PMA) application with the U.S. Food and Drug Administration (FDA).
NEVO III will be a non-randomized, single-arm trial evaluating clinical outcomes in approximately 1,200 patients throughout the U.S. and Canada. The primary endpoint will be TLF at 12-months. The study will be led by Dan Simon, M.D., Case Western Reserve University School of Medicine, Cleveland, OH; and David Kandzari, M.D., Scripps Clinic, San Diego, CA. NEVO(TM) will be compared to the CYPHER(R) Stent control arm of the CYPHER Stent/DAPT (dual anti-platelet therapy) trial (described below).
The CYPHER(R) Stent/DAPT trial will enroll approximately 2,000 patients and will compare clinical outcomes in a broad range of patients receiving DAPT for 12 months versus 30 months after receiving a CYPHER(R) Stent. This trial will contribute to the company’s involvement in a broader DAPT clinical program, required by the FDA, which involves all FDA-approved drug eluting stents.
“The NEVO RES I, NEVO II and NEVO III trials will provide us with comparative data for NEVO(TM) against Taxus(R) Liberte(R), Xience(R) and even our own CYPHER Stent,” said Dr. Rogers. “These data will provide physicians and their patients with important information to assess optimal treatments for coronary artery disease.”
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson & Johnson company, has been a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
**The third party trademarks used herein are trademarks of their respective owners.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Cordis Corporation s and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson s Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Cordis Corporation nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
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